FDA Warns Chinese Company Over CAPA, Procedural Violations

A host of issues related to corrective and preventive action procedures, device history records and quality system verifications landed a Chinese devicemaker a seven-citation FDA warning letter.

According to the Sept. 19 letter posted online Oct. 8, Anji Zheng Bang Medical Instrument’s CAPA procedures do not require it to document an investigation linked to a nonconformance and it does not verify or validate that corrections were effectively implemented. An external auditor was brought in to initiate and document CAPAs, but the procedure does not specify that the auditor be qualified to conduct those tasks.

“There was no documentation to show that information from these CAPA records was passed on to the persons responsible for conducting the investigation to determine root cause and to make necessary corrections,” the letter states.

The company also failed to ensure that a process that could not be fully verified by further testing and inspection would be validated “with a high degree of assurance” and approved vis à vis established procedures, the FDA says. For instance, the company had no documentation that process validation or revalidation activities were carried out for processes used to make a blood-piercing device, 9-inch forceps device and catheter insertion kit. There also was no documentation for such activities following specification and parameter changes to the blood-piercing device.

During the July 1-4 inspection, the FDA investigator found the company lacked procedures to ensure that device design was properly translated to production specifications for the three devices. Moreover, there were no procedures for environmental controls and the environmental control system was not reviewed regularly to ensure it was functioning adequately, the letter says.

Other problems noted by the FDA investigator were:

• Failure to maintain record of complaint investigations;

• Failure to establish and maintain procedures to control all documents required by the Quality System Regulation; and

• Failure to maintain device history records and procedures to ensure DHRs are maintained for each batch, lot or unit of the company’s products.

The company, located in Anji County, Zhejiang Province, lacks a DHR procedure, and its DHR for the blood-piercing device fails to specify the location of the primary identification label for each production batch, the warning letter says. The production inspector failed to review or sign a production record for the 9-inch forceps following a shift change, the letter adds.

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